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Gradual vs. Abrupt Cessation Treatment for Smoking

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ClinicalTrials.gov Identifier: NCT00297492
Recruitment Status : Completed
First Posted : February 28, 2006
Results First Posted : September 5, 2012
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Hughes, University of Vermont

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Behavioral: Reduction Phone Counseling
Behavioral: Abrupt Phone Counseling
Behavioral: Minimal Abrupt Phone Counseling
Drug: Pre-Quit Nicotine Lozenges
Drug: Post-Quit Nicotine Lozenges
Enrollment 750
Recruitment Details Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico.
Pre-assignment Details Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment.
Arm/Group Title Gradual Reduction Abrupt Cessation Minimal Intervention
Hide Arm/Group Description Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date Minimal intervention to mimic intervention at a primary care office
Period Title: Set Quit Date
Started 297 299 150
Completed 290 286 145
Not Completed 7 13 5
Reason Not Completed
Lost to Follow-up             7             13             5
Period Title: 6 Month Follow-up
Started 290 286 145
Completed 227 237 118
Not Completed 63 49 27
Reason Not Completed
Lost to Follow-up             63             49             27
Arm/Group Title Gradual Reduction Abrupt Cessation Minimal Intervention Total
Hide Arm/Group Description Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date Minimal intervention to mimic intervention at a primary care office Total of all reporting groups
Overall Number of Baseline Participants 297 299 150 746
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 299 participants 150 participants 746 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
273
  91.9%
276
  92.3%
139
  92.7%
688
  92.2%
>=65 years
24
   8.1%
23
   7.7%
11
   7.3%
58
   7.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 297 participants 299 participants 150 participants 746 participants
48  (13) 48  (12) 47  (13) 48  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 299 participants 150 participants 746 participants
Female
159
  53.5%
165
  55.2%
80
  53.3%
404
  54.2%
Male
138
  46.5%
134
  44.8%
70
  46.7%
342
  45.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 297 participants 299 participants 150 participants 746 participants
297 299 150 746
1.Primary Outcome
Title Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement
Hide Description Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.
Arm/Group Title Gradual Reduction Abrupt Cessation Minimal Intervention
Hide Arm/Group Description:
Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.
Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.
Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
Overall Number of Participants Analyzed 297 299 150
Measure Type: Number
Unit of Measure: participants
12 20 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gradual Reduction, Abrupt Cessation, Minimal Intervention
Comments

Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up

Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments Statistical significance was determined by a two-sided p value less than 0.05.
Method Chi-squared
Comments Degrees of freedom = 2
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gradual Reduction, Abrupt Cessation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.28 to 1.22
Estimation Comments The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gradual Reduction Abrupt Cessation Minimal Intervention
Hide Arm/Group Description Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date Minimal intervention to mimic intervention at a primary care office
All-Cause Mortality
Gradual Reduction Abrupt Cessation Minimal Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Gradual Reduction Abrupt Cessation Minimal Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/297 (0.00%)   0/299 (0.00%)   0/150 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gradual Reduction Abrupt Cessation Minimal Intervention
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/297 (0.00%)   0/299 (0.00%)   0/150 (0.00%) 
Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Hughes
Organization: University of Vermont
Phone: 802-656-9610
EMail: John.Hughes@uvm.edu
Layout table for additonal information
Responsible Party: John Hughes, University of Vermont
ClinicalTrials.gov Identifier: NCT00297492    
Other Study ID Numbers: R01DA011557-07 ( U.S. NIH Grant/Contract )
R01DA011557-07 ( U.S. NIH Grant/Contract )
First Submitted: February 24, 2006
First Posted: February 28, 2006
Results First Submitted: May 31, 2012
Results First Posted: September 5, 2012
Last Update Posted: September 20, 2013